Update: The following update relating to this announcement has been issued:

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

February 18, 2010 - See Notice NOT-DA-10-010 Notice to Clarify Other Submission Requirements.

Program
Announcement (PA) Number: PAR-10-068

NOTICE: Applications submitted in response
to this Funding Opportunity Announcement (FOA) for Federal assistance must be
submitted electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT
BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)93.279

Key
Dates
Release/Posted
Date: December 18, 2009
Opening Date: February 1, 2010 (Earliest
date an application may be submitted to Grants.gov) Letters of Intent Receipt Date(s):Not applicableNOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization). Application Due Date(s): March 1, 2010Peer Review Date(s): April 2010. Council Review Date(s):Not applicable Earliest Anticipated Start Date(s):Not applicable Additional Information To Be
Available Date (Activation Date):Not ApplicableExpiration Date: March 2, 2010

Due Dates for E.O. 12372 Not Applicable

Additional
Overview Content

Executive Summary

Purpose. The NIDA Avant-Garde Award
Program for HIV/AIDS Research is meant to complement NIDA’s traditional
investigator-initiated grant programs by supporting individual scientists
of exceptional creativity who propose high-impact research that will open new
avenues for prevention and treatment of HIV/AIDS among drug abusers. The
term “avant-garde” is used to describe highly innovative approaches that
have the potential to be transformative— open new areas of research or
lead to new avenues of treatment and prevention for HIV/AIDS among drug
abusers. The proposed research should reflect ideas substantially
different from those already being pursued by the investigator or others.
The research proposed must be in an area described in the Trans – NIH Plan
for HIV-Related Research (http://www.oar.nih.gov/strategicplan/fy2010/index.asp).

The
2010 Avant-Garde Award competition will proceed in two phases. The X02 pre-application
is the first phase. X02 pre-applications will be reviewed by external
reviewers to identify the most outstanding applications (applications from
individuals of exceptional creativity who propose highly significant and
innovative projects that are not appropriate for traditional grant
mechanisms). Those investigators whose
submissions are judged to be the most outstanding will be notified of the
opportunity to submit full applications under RFA-DA-10-012.
All awards will be made under RFA-DA-10-012.
No awards will be made under this announcement. For additional
information, consult the FAQs at http://drugabuse.gov/avgp.html.

Mechanism
of Support. This announcement utilizes the X02 mechanism for submission and
consideration of pre-applications. Pre-applications are a necessary first
step in applying for a 2010 Avant-Garde Award. .

Funds
Available and Anticipated Number of Awards. No awards will be
made under this announcement. Through the associated FOA (RFA-DA-10-012),
NIDA expects to commit approximately $ 2 million per year for 5 years to fund
2-3 awards.

Budget and Project Period. No awards will be made under this announcement. Awards
through RFA-DA-10-012 will be for $500,000 in direct costs each year for five years, plus
standard F&A costs, which will be determined at the time of award.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Individuals with the skills, knowledge, and
resources necessary to carry out the proposed research are invited to work
with their institution/organization to develop an application. Women and individuals from racial and ethnic groups underrepresented in the
biomedical and behavioral sciences as well as individuals with
disabilities are always encouraged to apply for NIH support. Investigators
at all career levels who are currently engaged in research are eligible to
submit an application. We also encourage investigators who have not been
previously involved in drug abuse research to consider the scientific
opportunity to contribute to this field. Recipients of the Avant-Garde
Award (DP1) are required to commit the major portion (at least 51%) of
their research effort to activities supported by the Avant-Garde Award.
Applicants who were not selected for an award in prior years may submit
applications this year. There are no citizenship or residency
requirements.

Number of PDs/PIs. Only one PD/PI (i.e., no
multiple PDs/PIs), may be designated on the application.

Number of Applications. Individuals may submit only one
application. There is no limit to the number of
applications that an institution may submit.

Resubmissions. Resubmissions are not allowed. All
applications must be submitted as “new” regardless of any previous submissions
to the program.

Application
Materials. See Section IV.1 for application materials.
All applications, including resubmission, revision and renewal, submitted for
due dates January 25, 2010 and beyond, must utilize the current forms and
instructions.

General Information. For general
information on SF424 (R&R) Application and Electronic Submission, see these
Web sites:

This award is designed to support individual
scientists of exceptional creativity who propose cutting edge – and possibly
transformative – approaches to major challenges in biomedical and behavioral
research on HIV/AIDS that are relevant to drug abuse. The term “avant-garde” is
used to describe highly innovative approaches that have the potential to be
transformative. It is hoped that this high-impact research will open new
areas of HIV/AIDS research and/or lead to new avenues for treatment and
prevention of HIV/AIDS among drug abusers. Proposed research should reflect
ideas substantially different from those already being studied by the
investigator or others. Biomedical and behavioral research is defined broadly
in this announcement as encompassing scientific investigations in the
biological, behavioral, clinical, social, physical, chemical, computational,
engineering, and mathematical sciences. The award is meant to support
individuals who intend to pursue research directions that are not readily
supported by other NIH grant mechanisms. The program is not intended simply to
expand the funding of an already supported research project, but rather to
support highly creative researchers to pursue visionary concepts and approaches
to research on HIV/AIDS.

This announcement utilizes the X02 mechanism for
submission of pre-applications. Pre-applications are a necessary first step in
applying for a 2010 Avant-Garde Award. Pre-applications will be evaluated by a
group of external experts. Those investigators whose projects are judged to be
the most outstanding will be notified of the opportunity to submit full (DP1)
applications under RFA-DA-10-012.

Avant-Gardeawardees are required to commit the
major portion (at least 51%) of their research effort to activities supported
by the Avant-Garde Award program. Those who will not be able to meet this
requirement should not submit pre-applications.

This FOA uses the
X02 pre-application mechanism for submission of applications.
Pre-applications are a necessary first step in applying for a 2010 Avant-Garde
Award. Pre-applications will be assessed by a group of external
reviewers. Those applicants whose pre-applications are identified as
being outstanding (individuals of exceptional creativity with highly innovative
projects that are not suited to standard grant mechanisms) will be notified of
the opportunity to submit full applications under RFA-DA-10-012 (DP1). The Project Director/Principal Investigator (PD/PI) will be solely
responsible for planning, directing, and executing the proposed project.

2.
Funds Available

All
awards will be made under RFA-DA-10-012.
No awards will be made under this FOA.

Any individual with the skills, knowledge, and
resources necessary to carry out the proposed research as the PD/PI is invited to work with
his/her organization to develop and submit an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support.
Those at early to middle stages of their careers, and women and members of
groups underrepresented in biomedical or behavioral research are especially
encouraged to apply. Investigators
who have not been previously involved in drug abuse research are encouraged to
consider the scientific opportunity to contribute to this field.

Investigators at all career levels who meet the
eligibility criteria and are currently engaged in research are eligible to
submit applications. The research proposed need not be in a conventional
biomedical or behavioral discipline; if the individual’s experience is in
non-biological areas, however, he/she must demonstrate a commitment to
exploring topics of biomedical or behavioral relevance to HIV/AIDS and drug
abuse.

This initiative is to support investigators who intend
to pursue new research directions – research that is distinct from that
currently or previously conducted by the investigator. Applications for
projects that are extensions of ongoing research should not be submitted.
DP1 awardees are required to commit the major portion (at least 51%) of their
research effort to activities supported by the Avant-Garde Award program.
Those who will not be able to meet this requirement should not submit
pre-applications.

Investigators who were not selected for an award in
prior years may submit pre-applications this year; however, all
pre-applications must be submitted as “new” applications regardless of any
previous submission to the program.

Only one PD/PI (i.e., no multiple PDs/PIs) may be
designated on the pre-application. NIH intramural investigators are not
eligible for support under this program.

Number
of Applications. An individual may not submit more than one application.
There is no limit to the number of applications institutions may submit.

Resubmissions.Resubmissions
of applications are not allowed. All applications will be considered
“new” regardless of any previous applications to the Avant-Garde Award Program
for HIV/AIDS Research.

Renewals. Not applicable..

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the steps of the
registration process could take four weeks or more. Therefore, applicants should
immediately check with their business official to determine whether their
organization/institution is already registered with both Grants.gov and the Commons.
All registrations must be complete by the submission deadline for the
application to be considered “on-time” (see 3.C.1 for more information about
on-time submission).

A one-time registration
is required for institutions/organizations at both:

The individual
designated as PD/PI on the application must be registered also in the NIH eRA
Commons.

The PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons
account for both an Authorized Organization Representative/Signing Official
(AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an
Internet Assisted Review (IAR) role, both roles should exist under one Commons
account.

This
registration/affiliation must be done by the AOR/SO or his/her designee who is
already registered in the Commons.

Both the PD(s)/PI(s)
and AOR/SO need separate accounts in the NIH eRA Commons since both are
authorized to view the application image.

Note that for this FOA, only one PD/PI will be allowed
(i.e., no multiple PD/PIs).

Note: The registration process is not
sequential. Applicants should begin the registration processes for both
Grants.gov and eRA Commons as soon as their organization has obtained a DUNS
number. Only one DUNS number is required and the same DUNS number must be
referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

1.
Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the “Credential” log-in
field of the “Research & Related Senior/Key Person Profile” component must
contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions
for such fields are clearly identified in the Application Guide. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all
dates.) If an
application is not submitted by the due date(s) and time, the application may
be delayed in the review process or not reviewed. All applications must meet
the following criteria to be considered “on-time”:

All
registrations must be complete prior to the submission deadline

The application
must receive a Grants.gov tracking number and timestamp (or eRA help desk
ticket confirming a system issue preventing submission) by 5:00 p.m. local time
on the submission deadline date.

Any system
identified errors/warnings must be corrected and the submission process
completed within the “error correction window.”

Submission to Grants.gov is not the last step – applicants must follow
their application through to the eRA Commons to check for errors and warnings
and view their assembled application!

3.C.2 Two Day
Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been
successfully submitted through Grants.gov,NIH provides
applicants a two day error correction window to correct any eRA
identified errors or warnings before a final assembled application is created
in the eRA Commons. The standard error correction window is two (2) business
days, beginning the day after the submission deadline and excluding weekends
and standard federal holidays. All errors must be corrected to successfully
complete the submission process. Warnings will not prevent the application
from completing the submission process.

Please note that the following
caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that
includes additional changes.

Proof of “on-time” submission (e.g., Grants.gov timestamp and
tracking number) and description of all changes made within the window must be
documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing
an Application in the eRA Commons

Once any eRA identified errors have been addressed and
the assembled application has been created in the eRA Commons, the PD/PI and the Authorized
Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday
– Friday, excluding Federal holidays) to view the assembled application before it automatically moves
forward to NIH
for further processing.

If everything is acceptable, no
further action is necessary. The application will automatically
move forward to the Division of Receipt and Referral in the Center for
Scientific Review for processing after two weekdays, excluding Federal holidays.

Prior to the submission deadline, the
AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and
submit a Changed/Corrected application. In
these cases, please contact the eRA Help Desk to ensure that the issues
are addressed and corrected. Once rejected, applicants should follow the
instructions for correcting errors in Section 2.12, including the
requirement for cover letters on late applications. The
“Reject” feature should also be used if you determine that warnings are
applicable to your application and need to be addressed now. Remember,
warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two weekdays if no action is taken. Some warnings may
need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for an
eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay should be
explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.

There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on their
application status in the Commons.

The following instructions are specific to the
Avant-Garde Award X02 pre-applications and are exceptions to the general SF424
instructions. Pre-applications that do not conform to the specific
instructions detailed below will not be assessed.

NOTE: Letters of reference are not required and will
not be accepted with pre-applications. Reference letters will be required
of those applicants submitting full (DP1) applications to RFA DA-10-012.

All of the following must be submitted for the
pre-application to be considered complete:

I. Area of Science Designation:

Applicants
must choose a research area from the following list taken from the Trans-NIH
Plan for HIV-Related Research:

Foundational
Research

(01)
Natural History and Epidemiology

(02)
Etiology and Pathogenesis

Prevention
Research

(03)
Microbicides

(04)
Vaccines

(05)
Behavioral and Social Science

Therapeutics

(06)
Therapeutics

The areas of science are used by NIDA staff to assist
in assigning pre-applications to the most appropriate reviewers. Include the
area of science at the beginning of your essay. Putting the area of science in
the essay will facilitate assigning your pre-application for review.

II. Abstract: An abstract no
longer than 1 page describing the goals of the project. The abstract must
contain text only – no figures, animations, or web links to provide further
information. The abstract should contain a brief statement describing how
the proposed research may lead to new avenues for the treatment and prevention
of HIV/AIDS among drug abusers. The abstract should be uploaded as an
attachment for item 7, Project Summary/Abstract, on the Other Project
Information component of the application.( SF424)

III. Public Health Relevance Statement: The Public Health Relevance statement is a brief
statement (2-3 sentences) written in plain language about how the proposed
research can positively impact HIV/AIDS treatment or prevention among drug
abusers. This statement should be uploaded for item 8, Project
Narrative, on the Other Project Information component of the application
(SF424).

V. Specific
Aims.This is limited to one
page. Specific aims may describe the techniques to be used to attain
objectives and alternate strategies that will be employed if the initial
approach is not fully successful. Indicate how the successful completion of
this course of researchwould open new avenues of research or
lead to new treatment and prevention for HIV/AIDS among drug abusers. This
should be uploaded as an attachment to #2 Specific Aims of the PHS 398 Research
Plan.

IV. Essay: An essay of 3-5 pages
that addresses the investigator's innovative vision for, and the significance
of, the HIV/AIDS biomedical or behavioral problem to be addressed, and his/her
qualifications to engage in groundbreaking research. The essay should describe
the individual's view of the major challenges in HIV/AIDS biomedical or
behavioral research to which he/she can make seminal contributions. No detailed
scientific plan should be provided since the research plan is expected to
evolve during the tenure of the grant. The essay should include the following
in the order given with the headings as shown:

1. Science Area: The Area of Science (-e.g., 01 – Natural History and
Epidemiology) and project title must be included at the beginning of the Essay.

2.Project Description: What is the scientific problem that will be
addressed, and why is this important? What are the visionary, and possibly
high-risk, approaches that, if successful, might lead to groundbreaking or
paradigm-shifting results?

3. Evidence of Innovativeness:
What concrete evidence can you provide for your claim of innovativeness? For
example, qualities common to many highly innovative people include an interest
in, and the ability to integrate, diverse sources of information; an
inclination to challenge paradigms and take intellectual risks; persistence in
the face of failure; an ability to attract the right collaborators; and the
energy and concentration necessary to plan and execute effective strategies for
accomplishing goals.

5. How the Planned Research Differs From My Past or Current Work: Describe
how the project represents a new and distinct direction for your research.

6.Suitability for Avant-Garde Award Program: Why is the planned research
uniquely suited to the stated goal of the Avant-Garde Award program, rather
than a traditional grant mechanism?

Information
on collaborations may be included in the essay. Literature references are not
required, but, if included, must fit within the five-page limit. Figures
and illustrations may be included but must also fit within the five-page
limit. Do not include links to websites to provide further information.
No animations (movies) are allowed in any documents. The essay should be
uploaded as an attachment in #3 in the Research Strategy section of the PHS398
Research Plan.

VI. Most Significant Research Accomplishment. This is limited to one page. Publications or similar documents will
not be accepted. This should be uploaded using item 12, Other Attachments,
on Other Project Information Component of the application (SF424).

VII. Biographical Sketch: A two-page biographical sketch for the PD/PI only. (Use the
sample format shown in the URL in Section 4.5.2 of the Application Guide,
omitting Section C, Research Support) Only the Biographical Sketch
of the submitting individual should be submitted. No other biographical
sketches for other key personnel should be submitted. The Biographical
Sketch is uploaded on the Research & Related Senior/Key Person Component (SF424).
.

VIII. List of Current and Pending Research Support: A list of current and pending research support
from all sources, including current year direct costs and percent effort
devoted to each project. (Use the format shown in Section 3.1.1.8 of the
Application Guide.) An effort commitment statement (described below) must be
included in this document. A brief statement of the facilities to be used
for the conduct of the research must also be included in this document. This
document is uploaded on the Research & Related Senior/Key Person
Component(SF424).

IX. Effort Commitment: Awardees are
required to commit at least 51% of their research effort to the project
supported by the Avant-Garde Award. In their list of current and pending
support, individuals must include a statement to indicate that, if chosen to
receive an award, the individual will commit a minimum of 51% of his/her
research effort to the project supported by the Avant-Garde Award.

Special
requirements for completing the SF424 (R&R) application are specified
below. In addition:

For Budget request, enter zero for all
categories. No awards will be made in response to the pre-application FOA.

No other documentation, such as letters of
collaboration or biographical sketches of other personnel will be
accepted. Information about personnel other than the PD/PI is not
required, but may be included within the 3-5-page essay.

Format
specifications for Text (PDF) Attachments: All attachments must be in PDF format. Follow format specifications
for PDF attachments in the Application Guide
(http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf)

All instructions outlined in the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf are to be followed, incorporating “Just-in-Time” information concepts, with
the following exceptions, which are specific requirements for Avant-Garde Award
pre-applications. Pre-applications that do not conform to the specific instructions
detailed below will not be reviewed.

1.
SF424 (R&R) COVER COMPONENT

Item Number and Title

Instructions

1.
Type of Submission

Must
be “Pre-Application”

8.
Type of Application

Must
be “New”

12.
Proposed Project

Enter
start date: 09/30/2010; Enter end date: 07/31/2015

15a. Total Federal Funds Requested

Enter
$0

15b. Total Non-Federal Funds

Enter
$0

15c. Total Federal and Non-Federal Funds

Enter
$0

15d. Estimated Program Income

Enter
$0

2.
RESEARCH & RELATED PROJECT/PERFORMANCE SITE LOCATIONS

Complete as appropriate.

3. RESEARCH & RELATED OTHER PROJECT INFORMATION
COMPONENT:

Item Number and Title

Instructions

1.
Are Human Subjects Involved?

Check “No.”Detailed plans regarding protection of human subjects,
inclusion of women and minorities, targeted/planned enrollment, and inclusion
of children are not required and should not be submitted with this
pre-application. This information will be required from only those
individuals who submit a full application in response to RFA 10-012.

2.
Are Vertebrate Animals Used?

Check
“No.” Detailed information regarding the use of vertebrate animals is not
required at the time of submission. This information will be required only
from those individuals who submit a full application in response to RFA
10-012,

Note: Applications found not to comply with
the page limit requirements or that contain attachments other than those
specified will be rejected.

4.
SF424 (R & R) SENIOR/KEY PERSON PROFILE COMPONENT:

Complete
items only for Project Director/Principal Investigator. Do not submit profiles
for other senior/key personnel.

Item Title

Instructions

Profile-
PD/PI – Attach Biographical Sketch

Attach biographical sketch here (two-page maximum, PDF format). Use the form
shown in the URL in Section 4.5.2 of the Application Guide, omitting Section
C, Research Support (see below).

Profile-
PD/PI – Attach Current & Pending Support

Attach
a list of Current and Pending Support here (PDF format). Use the form
shown in Section 3.1.1.8 of the Application Guide. Be sure to include
statement affirming that you will devote at least 51% of research effort to
Avant-Garde Award project. Also, include a brief statement of the facilities
to be used for the conduct of the research

Profile
– Senior Key Person 1

Do not use. Submit
information only for PD/PI.

Note: Pre-applications found not to comply with the page
limit requirements will be rejected during the agency validation process.

5.
PHS398 COVER PAGE SUPPLEMENT

Item Title

Instructions

2.
Human Subjects

Omit.

4.
Human Embryonic Stem Cells

Enter
‘yes” or “no” as appropriate.+

6.
PHS398 Research Plan Component Sections

Item Number and Title

Instructions

1.
Introduction to Application (for Resubmission or Revision only)

Omit

2.
Specific Aims

Required
1 page attachment (PDF Format) to Item#2

3.
Research Strategy

Attach
3 – 5 page essay (PDF format). Include area of science (e.g., (01 – Natural
History and Epidemiology) and project title on first page of essay.
Information on collaborations may be included in the essay. Literature
references are not required but if included must fit within the five-page
limit. Figures and illustrations may be included but must also fit
within the five-page limit. Do not include links to websites for further
information. Do not include animations. Item #3 PHS 398

7.
PHS 398 Cover Letter File (Optional):

Cover
letters should be included only when submitting late applications or
Changed/Corrected applications after the submission deadline. Do not submit
cover letters for initial submissions or for changed/corrected applications
submitted before the submission deadline. The cover letter should contain only
the following information:

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

Appendix
Materials

Appendices
are not allowed and will not be accepted.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to
this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not Applicable

Genome Wide Association Studies (GWAS). Not
Applicable

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

2.
Review and Selection Process

Review Process

Pre-applications that are complete will be evaluated by a
multidisciplinary group of outside experts convened by NIDA with expertise in
HIV/AIDS and drug abuse, who will evaluate pre-applications based on the
criteria listed below. PIs with the most outstanding pre-applications
(best address the review criteria) will be notified of the opportunity to
submit full applications for the Avant-Garde Award in response to RFA-DA-10-012.
Please note that RFA-DA-10-012 includes additional review criteria of significance, investigator(s), innovation,
approach, , and environment.

In
particular, reviewers will evaluate:

The scientific problem to be addressed: The biomedical or behavioral
significance/importance of the problem; the likelihood that, if
successful, the project will have a significant impact on HIV/AIDS among
drug users (open new avenues of research and/or impact prevention and
treatment); and the innovativeness of the project.

The investigator: Evidence for the investigator’s claim of
innovativeness/creativity (taking into account the applicant's career
stage) and the demonstrated ability of the investigator to devote at least
51% of his/her research effort to activities supported by the Avant-Garde
Award.

The suitability for Avant Garde Award mechanism: Evidence that the
proposed project carries much higher levels of risk and potential impact
than typical of NIDA-supported research projects and evidence that the
proposed project represents a distinctly new scientific direction.

Additional Review Criteria

None

Additional Review
Considerations

None

3. Anticipated Announcement and Award Dates

Submitting individuals
will be notified by May 2010 whether or not they will notified of the
opportunity to submit full applications in response to the companion RFA-DA-10-012.

Section
VI. Award Administration Information

1. Award Notices

Not applicable.

2. Administrative and National
Policy Requirements

Not applicable.

3. Reporting

Not applicable.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (“NIH Policy for
Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local institutional review board (IRB) rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy,investigators
funded by the NIH must submit or have submitted for them to the National Library of
Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version
of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the
official date of publication. The NIH Public Access Policy is available
at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All applications and proposals for NIH funding
must be self-contained within specified page limitations. For publications
listed in the appendix and/or Progress report, Internet addresses (URLs) or
PubMed Central (PMC) submission identification numbers must be used for
publicly accessible on-line journal articles. Publicly accessible on-line
journal articles or PMC articles/manuscripts accepted for publication that are
directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in
the Catalog
of Federal Domestic Assistance athttp://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part
52 and 45 CFR Parts 74 and 92. All awards are subject
to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.